Institutional Review Board(IRB) Full Board Review - Minnesota Dept. of Health

Institutional Review Board (IRB) - Full Board Review

A full board review is one in which the study must be discussed and approved by majority vote at a meeting of the board.

Each proposed research project must be submitted on the IRB application form and include:

  1. A description of the Principal Investigator’s training about using human subjects in research from a recognized institution, such as the University of Minnesota or the Mayo Clinic. One of the online courses from the NIH or CDC can serve this purpose at a minimum.
  2. A description of the training about using human subjects in research received by anyone having access to identifiable data. (The IRB strongly recommends that any such people take an online course from the NIH or CDC. The Protecting Human Research Participants’ course from the NIH Office of Extramural Research, developed in July 2008 for academic researchers, meets this requirement. Researchers/practitioners register online for free at: NIH Office of Extramural Research)
  3. A detailed description of the research design and procedures as they affect human subjects;
  4. A list of precautions taken to safeguard the subjects’ welfare;
  5. A precise description of the research’s subject population;
  6. A description of the Informed Consent process and copies of all recruitment materials and consent forms to be used; and
  7. Methods to be used to protect data confidentiality and subject privacy.

The board will review proposals at regularly scheduled IRB meetings. The board will use the criteria outlined in this section to assign one of the following status types to the

  1. Approval
  2. Approval Pending Stipulations
  3. Deferral
  4. Disapproval

A majority vote determines the proposal’s status. The vote must include the presence of a non-scientist member. A quorum must be present for the vote. The IRB must record the number voting for, against, and abstaining. It must also record all stipulations, recommendations, and comments (as defined below) or reasons for disapproval.

Investigators will receive written notification of the proposal’s status approximately one week after the meeting. The notice will include a detailed description of stipulations that must be met before the IRB will grant approval. “Approval” status can be granted only after receipt and approval of the investigator’s written response to the IRB. The IRB will then notify the PI that the study has received final approval. Researchers may not begin data collection until the IRB Administrator and primary reviewer have reviewed and approved all stipulations and other requested materials.

In addition to formal stipulations, which must be met before starting data collection, the IRB may also make “suggestions” and “comments” in reviewing protocols, defined as follows:

Stipulations: approval with conditions that are mandatory (must be met) before final IRB approval and the beginning of research. The IRB will state these in its letter to the principal investigator and in the minutes of the meeting where the proposal was reviewed.

Suggestions: these are recommendations to the researcher, but are not mandatory for IRB final approval. These too will be stated in the letter to the principal investigator and in the minutes of the meeting where the proposal was reviewed.

Comments: these may or may not be included in the letter (depending on importance) and will not be recorded in the minutes unless related to a stipulation or suggestion.

Updated Friday, March 09, 2012 at 03:02PM